The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Oximax Npb-40 Handheld Pulse Oximeter.
| Device ID | K051352 |
| 510k Number | K051352 |
| Device Name: | OXIMAX NPB-40 HANDHELD PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Sarah Harrington |
| Correspondent | Sarah Harrington NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-24 |
| Decision Date | 2005-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521582498 | K051352 | 000 |
| 10884521181243 | K051352 | 000 |
| 10884521582613 | K051352 | 000 |
| 10884521177246 | K051352 | 000 |
| 10884521096738 | K051352 | 000 |
| 10884521582491 | K051352 | 000 |
| 10884521096752 | K051352 | 000 |